Prescription drug · ANDA
Neo-Synalar NDC 43538-940
neomycin sulfate and fluocinolone acetonide · Neomycin sulfate 3.5 mg/g; Fluocinolone acetonide .25 mg/g · Cream · Topical · Eurofarma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-940-60 | 43538094060 | 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBEMarketed from Jun 11, 1963 | |
| 43538-940-99 | 43538094099 | 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBEMarketed from Jun 11, 1963 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Neo-Synalar
- Generic name (nonproprietary)
- neomycin sulfate and fluocinolone acetonide
- Active ingredients
- Neomycin sulfate — 3.5 mg/gFluocinolone acetonide — .25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Eurofarma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 060700
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43538-940_b176bc29-53fc-48a1-bf09-ba250f1d13d7SPL ID b176bc29-53fc-48a1-bf09-ba250f1d13d7SPL set ID 1141956e-8a4c-4f80-95d1-f15bdb57fdf6RxCUI 1191359, 1542994UNII 057Y626693, 0CD5FD6S2M
- Pharmacologic class
- Aminoglycoside Antibacterial; Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443538094060followed by a unit qualifier and the quantityPackage 43538-0940-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE NEO-SYNALAR ® cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section) .
Excerpt only. Read the full label for complete information.